NCT07306949RecruitingPhase 4
Real-Life Clinical Efficacy of Acoramidis in Participants With ATTR-CM and Association With Cardiac Biomarkers
A Multicenter, Open-Label, Single Arm, Post-Marketing Clinical Study to Evaluate the Therapeutic Effects of Acoramidis Hydrochlorideon Cardiac Biomarkers and Current Clinical Features in Patients With Transthyretin-type Cardiac Amyloidosis: The CARE ATTR Study
Source: ClinicalTrials.gov · Last updated 7 Jan 2026
Brief summary (registry, in English)
The purpose of this study is to confirm that the treatment with acoramidis prevents the deterioration of the ATTR-CM disease progression index and that these indexes are surrogate markers of disease progression.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 15 Dec 2025
- Start date
- 1 Oct 2025
- Primary completion date
- 31 Mar 2028
- Lead sponsor
- Alexion Pharmaceuticals, Inc.
- Diseases
- Amyloidosis
- NCT number
- NCT07306949
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 200
- From 1 Oct 2025 to the primary completion date, 31 Mar 2028
- 15 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Likelihood of receiving a heart transplant within 1 year from the time screening begins
Other illness
- Hypersensitivity to acoramidis, its metabolites, or additives in the formulation has been confirmed.
- In the opinion of the responsible (sub)physician for the post-marketing clinical trial, has a history of drug abuse, alcoholism, or psychiatric disorder that would preclude compliance with this Post-Marketing Clinical Study Protocol
Lab values
- Switch participants: prior treatment with gene silencing agents (pachysilane sodium, butrisilane sodium) as treatment for ATTR-CM (including when specifically scheduled to start treatment with a gene silencing agent)
- Has a clinically significant medical condition, an abnormal laboratory test result, or a condition that may jeopardize the safety of the study participant, increase the risk of participation in the post-marketing clinical trial, or affect the study
Other
- Have confirmed diagnosis of AL amyloidosis
- Pregnant or lactating women
- Participating in an interventional study other than this study, including a clinical trial
Who the study is looking for
- Treatment history of ATTR-CM is one of the following:
- Naive participants: newly diagnosed with ATTR-CM and no prior treatment with drugs for ATTR-CM
- Switch participants: Participants who are using tafamidis, a TTR stabilizer, as treatment for ATTR-CM and who, in the judgment of the post-marketing clinical trial investigator (co-principal investigator), can be expected to benefit from switching to acoramidis.
- Naive participants must meet the following requirements:
- History of hospitalization for heart failure or heart failure symptoms requiring treatment, including diuretics
- Echocardiographic end-diastolic ventricular septal thickness greater than 12 millimeters (mm)
- Confirmed diagnosis of ATTR-CM (wild type or mutant) by one of the following diagnostic methods
- Tissue biopsy shows amyloid deposition and TTR precursor protein is identified by immunohistochemistry or mass spectrometry.
- Bone scintigraphy showing strong accumulation \*\* (Perugini score ≥ 2) consistent with myocardium and no M protein, negating the possibility of AL amyloidosis
Age in the registry: 18 years to 100 years · Sex: All · Does not accept healthy volunteers
Sites (15)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.